Identity
- Trade Name
- KeyPrint KeySplint Soft FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- The KeyPrint KeySplint Soft device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners. FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- The KeyPrint KeySplint Soft device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220173 FDA UDI
- FDA Product Code
- MQC FDA UDIKMY FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
KeyPrint KeySplint Soft by Johns Dental Laboratory — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Johns Dental Laboratory
Sources (1)
- FDA UDI 09b06cad-4a69-4ca9-8d87-38a8b29ffeb7 34 fields · synced May 30, 2026